What's New in eSubmission Today? eSubmission: Projects
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Introduction

To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.

The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.

Preparation of the next major version (version 4.0) is now ongoing within the ICH.

For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.

For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.

The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.

For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.

For details on how to find us please click here.

eSubmission eAFRSS news feed

Previous news is available here

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What's New in eSubmission Today?

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28-04-2022

Invitation to register to DADI-PMS Webinar - “Variations Form for Human Medicinal Products - What will happen at Go-Live”, 16/05/22 h. 10:00-12:00 (CET)

EMA is pleased to announce a new public webinar on the Digital Application Dataset Integration (DADI) Network Project Human Variations web-form go-live and its interaction with Product Management Service (PMS). The event will take place on 16 May 2022 at 10:00-12:00 Central European Time (CET).

More details are available here.

DADI-PMS Webinar Agenda - Variations Form for Human Medicinal Products - What will happen at Go-Live

26-04-2022

Updated versions of the eAF v1.26.0.0 (bug fix version) now available

Updated versions 1.26.0.0 of all eAFs are now available on the eAF website here. An updated human and veterinary MAA forms, Variation forms and the updated Renewal form are ready for immediate use. The changes implemented in this version are bug fixes and business rule corrections only and there is a limited impact to users. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary).
It is strongly recommended to use this latest version (document properties date 26.04.2022). Please note that there is no version number change.

More details can be found from the release notes available here.

21-04-2022

eSubmission Gateway Web Client upgrade - Migration of all (XCOMP) users to Syncplicity starting now

The preparations for the external UAT are almost finalised and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). The link to the test system and details on how to send test submissions will be published as soon as they become available.

There is no need to register for the UAT, and the link to the system will be provided via this website.

The migration of all existing XCOMP environment users to Syncplicity starting today - please note that you will be receiving an email from Axway Syncplicity with a link to reset your password for the XCOMP (test) environment. This resetting of the password has no impact in the password in production eSubmission Gateway Web Client.

The vgateway (old XCOMP environment) is currently not accessible.

The new Web Client (Axway Syncplicity) will be implemented in production environment in May 2022 following successful user acceptance testing.

Clarification on Variations Not Requiring Assessment (VNRA) availability in the Common Repository (vet domain)

Variations Not Requiring Assessment (VNRAs) are procedures only dealt with within the Union Product Database (UPD), without involvement of the rapporteurs. However, to continue to have a complete overview of a product life cycle including all post-authorisation procedures, VNRAs for Centrally Authorised Products will also be available in the Common repository, for reference only.

Updated General FAQ relating to eSubmission for Veterinary Applications is now available

The General FAQ relating to eSubmission for Veterinary Applications has been updated and is now available here.

A draft eCTD v4.0 implementation timeline

A draft timeline for the implementation of eCTD v4.0 in the EU was published in the ICH website in January 2022. This draft timeline is now also available on the eCTD v4.0 page here.

31-03-2022

Recordings from the DADI public webinars held on 18th and 25th January 2022 now available

The recordings from both DADI public webinars held in January are now available here for the 18th and here for the 25th of January 2022.

31-03-2022

Updated versions of the eAF v1.26.0.0 (bug fix version) now available

Updated versions 1.26.0.0 eAFs are now available on the eAF website here. An updated human and veterinary MAA forms, Renewal form and veterinary variation form are ready for immediate use. The changes implemented in this version are minor bug fixes only and they do not affect most users. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary) and the users can select if they wish to continue using the previously published version or the updated version (there is no version number change or any changes to the Data Exchange Standard (DES)).

More details can be found from the release notes available here.

Updated version of the eSubmission Gateway error codes document now available

An updated version of the eSubmission Gateway Error codes document is now available here.
The error codes document is useful to find out more details on why your submission via the eSubmission Gateway has failed.

eSubmission Gateway Web Client upgrade - UAT planned for April 2022

The EMA eSubmission team is pleased to announce that a project to upgrade the eSubmission Gateway Web Client is ongoing and the updated version of the Web Client (Axway Syncplicity) will be implemented in May 2022 subject to successful user acceptance testing planned to take place in April 2022.
More details and the call for volunteers to take part in the UAT will be published soon.

10-03-2022

Digital Application Dataset Integration (DADI) Network Project Technical Webinar (FHIR) 25/01/2022 - Presentation and the FHIR mapping and examples now available

Please find the presentation and the FHIR mapping & examples the webinar on "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF" in the following link. Please note that the recording from the webinar will be published as soon as it becomes available.

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System demo: digital application dataset integration (DADI) and Product Management Service (PMS) - Live broadcast available

EMA has announced the first public system demo of 2022. In this system demo, EMA will demonstrate developments of DADI project and the PMS service. The system demo will take place on Tuesday 15 March 2022 at 09:00-11:00 (CET). As the original WebEx webinar has reached maximum registration, the EMA team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session.

No registration is required to follow the live broadcast on EMA's website, available from the event page. Kindly note the session will also be recorded and made available through EMA Corporate Website.

Please share any questions on the above system demo with us at eSubProgofficer@ema.europa.eu.

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eSubmission Gateway Web Client upgrade planned for Spring 2022

The EMA eSubmission team is pleased to announce that a project to upgrade the eSubmission Gateway Web Client is ongoing and the updated version of the Web Client (Axway Syncplicity) will be implemented in May 2022 subject to successful user acceptance testing planned to take place in April 2022.

This upgrade will result in need for an update of the user passwords to allow access to the updated system. Further details participation in the UAT and on the steps required from existing users will be published in advance of the change.

17-02-2022

DADI Project updated Questions and Answers document now available

The Digital Application Dataset Integration (DADI) Network Project team is pleased to announce that an updated version of the DADI Questions and Answers documents is now available here.

For general inquiries, please contact the DADI project team via eSubProgofficer@ema.europa.eu. For questions or comments around the content of this Q&A document, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI Q&A”) via the EMA service desk.
If you have a technical question about the DADI project, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI”) via the EMA service desk.

Reminder on the mandatory use of OMS in Centralised Procedure

The use of Organisation Management Service (OMS) data became mandatory for Centrally Authorised Product applications as of 1st November 2021.
Since then, Centralised Procedure application submissions not using OMS data, are being filtered out during EMA validation and sent back to the applicant for remedial action. For applicants and Marketing Authorisation Holders, remedial action includes populating data in the application form before resubmitting the updated application form. In addition, it may mean registering or enriching OMS data to make it available for use in the form.
Although most of the free text address fields in eAFs have been removed for Centralised Procedure applications, the EMA has noted that some applicants are still not registering their organisation data in OMS and/or are misusing the “proposed” section of the Variation form. Please note that it is very important to make use of the 'address' part of the 'proposed' field for the organisation addresses. The address details should not (in most cases) be included in the'free text' field for proposed.

It is important to update OMS first and then select the 'updated' OMS information in 'proposed' field, the 'present' field can, in cases where the OMS entry has been updated, be filled in manually.

In order to avoid the risk of delaying the processing of their applications EMA urges applicants to: follow the instructions provided in Questions and Answers about OMS, register OMS data, i.e. organisational information, in advance of any forthcoming application submissions consider the turnaround time for OMS change request processing when planning to submit applications.

If you have any questions on the use of OMS in general or use of OMS in the eAFs, please contact us using the EMA service desk.

11-02-2022

Technical issue on the eAF webpage affecting availability of the latest versions of the eAF v1.26.0.0 has been fixed

The updated versions 1.26.0.0 eAFs (Veterinary MAA and variation, human variation) were published on the eAF website on 20th of January 2022.
A technical issue has been identified which means that these latest versions were replaced by earlier versions (at some point around 5th of February). The issue has been now fixed and the latest version of the forms are now again available, but please note that if you have downloaded/used an eAF from the eAF website recently, please check the document properties to ensure that you are using the correct, latest version dated 17/01/2022.
For any issues with the eAFs, or any issues in relation to the VMP-Reg, please raise a call via the EMA service desk.

04-02-2022

DADI Project Update - Updated timeline for the release of Human variations forms

Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations forms for Human medicinal products, including key milestones, is now available here.

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Presentation from the first DADI public webinar held on 18 January 2022 now published

Please find the presentation from the webinar available at the following link. Please note that the recording from the webinar will be published as soon as it becomes available.

28-01-2022

Veterinary Medicinal Products Regulation (Regulation (EU 2019/6) enters into force – updated eSubmission systems/forms now available for mandatory use

eAF

The use of the updated version of 1.26.0.0 eAFs is now mandatory for all new veterinary variations and marketing authorisation applications. Please note that there is no transitional period and the v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.

The version 1.25.0.0 has now been removed from the website, however, it should be noted that the version of the form should not be changed during an ongoing procedure. This also applies to the veterinary procedures which have started prior to 28th of January 2022.

eSubmission Gateway XML delivery file

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a large number of changes to the delivery files for Veterinary submissions reflecting the requirements/changes from the VMP-Reg (e.g. addition of new submission types, removal of submission types/submission units that are no longer relevant, update of available business units in relation to submission types for which no ‘new applications’ can be made once the new legislation is in force and addition of new values for Submission format dropdown menu).

More details can be found from the release notes and the technical documentation available here.

Users should note that the delivery files created prior to the new release will not work after the go live.

Common Repository (NCAs only)

An updated version of the Common Repository User interface is now available. This new version reflects changes introduced by the VMP-Reg (addition of new cabinets for VAMF and VPTMF)

20-01-2022

Updated versions of the eAF v1.26.0.0 now available

Updated versions 1.26.0.0 eAFs are now available on the eAF website. An updated human variation form is ready for immediate use. The change implemented in this version is a minor business rule change only and it will not affect most users. The use of the v1.26.0.0 is mandatory since 1st January 2022 and the users can select if they wish to continue using the previously published version or the updated version.

Updated forms for veterinary applications are available for applicants and MAHs to familiarise themselves with the updated forms prior to the mandatory use of this version for veterinary submissions from 28th of January 2022. Please note that there will be no transitional period once these forms go-live on the 28th of January. The v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.

The main changes in this updated version of the veterinary forms (maa and variation) relate to the implementation of the Regulation (EU) 2019/6 for Veterinary Medicinal Products and the changes are those that were previously indicated as known issues in the release notes and other issues that were raised during the UAT and other issues that have been discovered by users since the publication of the forms on the 1st of December 2021.

The version 1.26.0.0 cannot be used for procedures prior to 28th January 2022, however, in the view of significant changes in the forms it is strongly recommended that applicants will carefully review the updated forms (maa and variation) prior to the mandatory use deadline in order to identify and report any issues in the implementation and thus allowing an opportunity to fix any issues found prior to 28th January 2022. The version 1.25.0.0 will remain available for use for veterinary procedures (maa and variation) until the mandatory use of v1.26.0.0

More details can be found from the release notes and the technical documentation available here.

Applicants are reminded that the version of the form should not be changed during an ongoing procedure. This also applies to the veterinary procedures which have started prior to 28th of January 2022, it is important to note that the version of the form must not be changed during an ongoing procedure.

For any issues with the eAFs, or any issues in relation to the VMP-Reg, please raise a call via the EMA service desk.

18-01-2022

A new version of the eSubmission Gateway XML delivery file is now available

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file (addition of new submission description ‘Raw data pilot submission’ for MAA ‘additional information’ (human domain only). Further information on the Raw data pilot submissions will be published soon and this new submission description should only be used when it has been previously agreed that the product is taking part in the pilot. The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.

Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.

14-01-2022

Digital Application Dataset Integration (DADI) Network Project Webinar 18/01/2022 – Live broadcast available

In a previous news published on 10 December 2021 EMA announced the upcoming webinar ”Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms” on 18 January 2022 at 10:30-12:00 Central European Time (CET). As the original WebEx webinar has reached maximum registration, the DADI Network Project team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session. The updated guidance enters into force 1st February 2022.

No registration is required to follow the live broadcast on EMA’s website available from the event page and from EMA’s broadcasting channel

At certain points throughout this session, participants will be able to ask questions and give their input via the audience interaction tool Slido. Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to the processing of your personal data as explained in the EMA Data Privacy Statement for Slido

Kindly note the session will also be recorded and made available through EMA Corporate Website.

Thank you for forwarding this message to your affiliated Members who wish to participate.

Please share any questions on the above webinar with us at eSubProgofficer@ema.europa.eu.

22-12-2021

Updated EU Harmonised technical eCTD guidance now available

An updated version of the EU Harmonised technical eCTD guidance and the related release notes are now available here. The updated guidance enters into force 1st February 2022.

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Final, updated Veterinary eSubmission Guideline and other relevant veterinary eSubmission documents are now available

An updated version of the Veterinary eSubmission Guideline and other relevant veterinary eSubmission documents updated to reflect the VMP-Reg are now available here.

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The EMA is closed 23 December 2021 to 3 January 2022 inclusive.

The EMA IT service desk closes at 18:30 (CET) on 22 December 2021.
A skeleton service will be available on 23rd, 27th, 28th, 29th, 30th and 31st (half day) December 2021, as well as on 3rd January 2022.
Please note that if the queries are complex or require specific expertise they may not be resolved until the service desk returns to normal service on 4 January 2022.

There will be no regulatory procedural support available during the EMA office closure.

We would like to advise to send all planned in December submission in timely manner considering limited availability of IT service desk during upcoming Christmas holiday.

10-12-2021

Invitation to register to the Digital Application Dataset Integration (DADI) Network Project Webinars

The Digital Application Dataset Integration (DADI) Network Project to replace electronic application forms is pleased to announce it's first public webinars which will take place on 18 January 2022, h. 10:30-12:00 Central European Time (CET) and on 25 January 2022, h. 10:30-12:00 Central European Time (CET).

Read more details here.

01-12-2021

eAF v1.26.0.0 now available

New version 1.26.0.0 of all eAFs is now available on the eAF website. The forms for human applications (maa, variation and renewal) are ready for immediate use. The use of the v1.26.0.0 for human procedures becomes mandatory after a short one-month transitional period on 1st January 2022. The version v1.25.0.0 of the human forms has been removed from the eAF website, however users can continue to submit applications using this version until the end of December 2021.

The main change in this version of the forms for human use relate to the mandatory use of OMS for Centralised Procedure applications. This version of the forms removes the free text fields in the forms when EU authorisation/Centralised Procedure is selected. Additionally, a bug fix relating to Medical Device section in the variation form has been provided.

The forms for veterinary applications are available for applicants and MAHs to familiarise with the updated forms prior to the mandatory use of this version for veterinary submissions from 28th of January 2022. Please note that there will be no transitional period once these forms go-live on the 28th of January. The v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.

The main changes in this version of the veterinary forms (maa and variation) relate to the implementation of the Regulation (EU) 2019/6 for Veterinary Medicinal Products.

The version 1.26.0.0 cannot be used for procedures prior to 28th January 2022, however, in the view of significant changes in the forms it is strongly recommended that applicants will carefully review the form prior to the mandatory use deadline in order to identify and report any issues in the implementation and thus allowing an opportunity to fix any issues found prior to 28th January 2022.
The version 1.25.0.0 will remain available for use for veterinary procedures (maa and variation) until the mandatory use of v1.26.0.0.

More details can be found from the release notes and the technical documentation available here.

Applicants are reminded that the version of the form should not be changed during an ongoing procedure. This also applies to the veterinary procedures which have started prior to 28th of January 2022, it is important to note that the version of the form must not be changed during an ongoing procedure.

For any issues with the eAFs, or any issues in relation to the VMP-Reg, please raise a call via the EMA service desk.

11-11-2021

Essential maintenance to PSUR and eSubmission Gateway

Please note that PSUR and eSubmission Gateway File Handler will be unavailable from Friday 12/11/2021 after 18:00, until Monday 15/11/2021 morning 8:00, due to essential maintenance. EMA gateway will, however, remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.

If you have any questions, please contact the IT service desk.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

 

 

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